Trial · NCT04172441
Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
NCT04172441, Phase 2, Phase 3, Completed, Zealand Pharma; results first posted 2025-03-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism. Trials, record NCT04172441. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04172441
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
- NCT number
- NCT04172441
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 12 participants, actual
- Lead sponsor
- Zealand Pharma
- Conditions
- Congenital Hyperinsulinism
- Interventions
- dasiglucagon, Placebo
- First posted
- 2019-11-21
- Last updated
- 2025-03-14
- Other registries' IDs
- eudract:2017-004545-24
- Results first posted
- 2025-03-14
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Intravenous Glucose Infusion Rate | Hours 36-48 after initiation of trial drug (Part 1) | Mean intravenous (IV) glucose infusion rate (GIR) in the last 12 hours of each treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration). |
| Secondary | Carbohydrates Administered | 0 to 48 hours after initiation of trial drug | Total amount (g) of carbohydrates administered during the crossover part of the trial (dasiglucagon or placebo administration) per day. |
| Secondary | Mean Intravenous Glucose Infusion Rate | 48 hours after initiation of trial drug (Part 1) | Mean IV GIR for each 48-hour treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration). |
| Secondary | Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute | Hours 36-48 after initiation of trial drug (Part 1) | Mean IV GIR below 10 mg/kg/minute in the last 12 hours of each treatment period during Part 1, the crossover part of the trial (dasiglucagon or placebo administration) (yes/no) |
| Secondary | Time to Complete Weaning Off Intravenous Glucose | Days 5 to 25 (Part 2) | Time in days to complete weaning off IV glucose administration during Part 2, defined as the first point in time when the patient had been off IV glucose administration for at least 12 hours. |
| Secondary | Hypoglycemia Event Rate in Part 2 | Days 5 to 25 | Hypoglycemia event rate, defined as number of hypoglycemic events when PG was \<70 mg/dL (or 3.9 mmol/L), as detected by self-monitored plasma glucose. |
| Secondary | Clinically Significant Hypoglycemia Events in Part 2 | Days 5 to 25 | Clinically significant hypoglycemia event rate, defined as number of events when PG was \<54 mg/dL (3.0 mmol/L), as detected by self-monitored plasma glucose. |
| Secondary | Time to Actual Hospital Discharge | Days 5 to 25 | Time in days to actual hospital discharge defined as the time from first exposure to the study drug in Part 2 to discharge from hospital. |
| Secondary | Time to Pancreatic Surgery | Days 5 to 25 | Time (days) to pancreatic surgery (sub-total or total pancreatectomy with a cutoff of ≥95%). |
| Secondary | Carbohydrates Administered | Days 5 to 25 | Total amount (g) of carbohydrates administered (regardless of the route) per day. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Intravenous Glucose Infusion Rate | Hours 36-48 after initiation of trial drug (Part 1) | mg/kg/minute | MEAN | |
| SECONDARY | Carbohydrates Administered | 0 to 48 hours after initiation of trial drug | g/day | MEAN | |
| SECONDARY | Mean Intravenous Glucose Infusion Rate | 48 hours after initiation of trial drug (Part 1) | mg/kg/minute | MEAN | |
| SECONDARY | Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute | Hours 36-48 after initiation of trial drug (Part 1) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Complete Weaning Off Intravenous Glucose | Days 5 to 25 (Part 2) | days | MEDIAN | |
| SECONDARY | Hypoglycemia Event Rate in Part 2 | Days 5 to 25 | Self-monitored plasma glucose episodes were set to missing after pancreatectomy; 2 patients had near-total or partial pancreatectomies during Part 2 of the study. | episodes per week | MEDIAN |
| SECONDARY | Clinically Significant Hypoglycemia Events in Part 2 | Days 5 to 25 | Self-monitored plasma glucose episodes were set to missing after pancreatectomy; 2 patients had near-total or partial pancreatectomies during Part 2 of the study. | episodes per week | MEDIAN |
| SECONDARY | Time to Actual Hospital Discharge | Days 5 to 25 | days | MEDIAN | |
| SECONDARY | Time to Pancreatic Surgery | Days 5 to 25 | days | MEDIAN | |
| SECONDARY | Carbohydrates Administered | Days 5 to 25 | Carbohydrates amount administered was set to missing after pancreatectomy; 2 patients had near-total or partial pancreatectomies during Part 2 of the study. | g/day | MEDIAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group69
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Intravenous Glucose Infusion Rate | Dasiglucagon | 4.33 | Standard Deviation 4.922 | mg/kg/minute | |
| Mean Intravenous Glucose Infusion Rate | Placebo | 9.51 | Standard Deviation 5.655 | mg/kg/minute | |
| Carbohydrates Administered | Dasiglucagon | 106.7 | Standard Deviation 53.72 | g/day | |
| Carbohydrates Administered | Placebo | 139.1 | Standard Deviation 57.35 | g/day | |
| Mean Intravenous Glucose Infusion Rate | Dasiglucagon | 6.9 | Standard Deviation 5.91 | mg/kg/minute | |
| Mean Intravenous Glucose Infusion Rate | Placebo | 10.4 | Standard Deviation 5.31 | mg/kg/minute | |
| Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute | Dasiglucagon | Mean IV GIR below 10 mg/kg/min in the last 12 hours of each treatment period during Part 1?: yes | 9 | Participants | |
| Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute | Placebo | Mean IV GIR below 10 mg/kg/min in the last 12 hours of each treatment period during Part 1?: yes | 6 | Participants | |
| Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute | Dasiglucagon | Mean IV GIR below 10 mg/kg/min in the last 12 hours of each treatment period during Part 1?: no | 3 | Participants | |
| Mean Intravenous Glucose Infusion Rate Below 10 mg/kg/Minute | Placebo | Mean IV GIR below 10 mg/kg/min in the last 12 hours of each treatment period during Part 1?: no | 6 | Participants |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1-1: First Intervention (48 Hours) | STARTED | Dasiglucagon, Then Placebo | 7 | |
| Part 1-1: First Intervention (48 Hours) | STARTED | Placebo, Then Dasiglucagon | 5 | |
| Part 1-1: First Intervention (48 Hours) | COMPLETED | Dasiglucagon, Then Placebo | 7 | |
| Part 1-1: First Intervention (48 Hours) | COMPLETED | Placebo, Then Dasiglucagon | 5 | |
| Part 1-1: First Intervention (48 Hours) | NOT COMPLETED | Dasiglucagon, Then Placebo | 0 | |
| Part 1-1: First Intervention (48 Hours) | NOT COMPLETED | Placebo, Then Dasiglucagon | 0 | |
| Part 1-2: Second Intervention (48 Hours) | STARTED | Dasiglucagon, Then Placebo | 7 | |
| Part 1-2: Second Intervention (48 Hours) | STARTED | Placebo, Then Dasiglucagon | 5 | |
| Part 1-2: Second Intervention (48 Hours) | COMPLETED | Dasiglucagon, Then Placebo | 7 | |
| Part 1-2: Second Intervention (48 Hours) | COMPLETED | Placebo, Then Dasiglucagon | 5 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events240
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tachypnoea | Respiratory, thoracic and mediastinal disorders | Part 1: Dasiglucagon | 1 | 12 | 1 |
| other | Tachypnoea | Respiratory, thoracic and mediastinal disorders | Part 1: Placebo | 1 | 12 | 1 |
| other | Tachypnoea | Respiratory, thoracic and mediastinal disorders | Part 2: Dasiglucagon | 1 | 12 | 1 |
| other | Tachypnoea | Respiratory, thoracic and mediastinal disorders | Parts 1 and 2: Dasiglucagon | 1 | 12 | 2 |
| other | Tachypnoea | Respiratory, thoracic and mediastinal disorders | Follow-up Period | 0 | 1 | 0 |
| other | Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Part 1: Dasiglucagon | 1 | 12 | 1 |
| other | Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Part 1: Placebo | 0 | 12 | 0 |
| other | Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Part 2: Dasiglucagon | 0 | 12 | 0 |
| other | Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Parts 1 and 2: Dasiglucagon | 1 | 12 | 2 |
| other | Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Follow-up Period | 0 | 1 | 0 |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Dasiglucagon | 0 | 12 |
| Total, all-cause mortality | Part 1: Placebo | 0 | 12 |
| Total, all-cause mortality | Part 2: Dasiglucagon | 0 | 12 |
| Total, all-cause mortality | Parts 1 and 2: Dasiglucagon | 0 | 12 |
| Total, all-cause mortality | Follow-up Period | 0 | 1 |
| Total, other adverse events | Part 1: Dasiglucagon | 3 | 12 |
| Total, other adverse events | Part 1: Placebo | 7 | 12 |
| Total, other adverse events | Part 2: Dasiglucagon | 10 | 12 |
| Total, other adverse events | Parts 1 and 2: Dasiglucagon | 10 | 12 |
| Total, other adverse events | Follow-up Period | 1 | 1 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04172441
GET https://conductscience.org/api/trials/v1/NCT04172441/registered?page=2